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A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier:
NCT00347542
First received: June 30, 2006
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the change in glucose and insulin metabolism(early markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.


Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent
Obesity
 Drug: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sitaram Bhartia Institute of Science and Research:

Primary Outcome Measures:
  • Oral Glucose Insulin Sensitivity (OGIS)

Secondary Outcome Measures:
  • Lipid profile
  • CRP
  • ApoA1
  • ApoB
  • Blood Pressure

Estimated Enrollment: 100
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.These results have been replicated in patients at risk for diabetes with documentation of impairment in insulin secretion in Vitamin D deficient subjects. Therefore, vitamin D could be implicated in the pathogenesis of type 2 diabetes, by affecting either insulin sensitivity or ß cell function, or both. However, there is paucity of literature on the effect of Vitamin D supplementation on insulin resistance or glucose metabolism. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • ≥35 years of age
  • Waist circumference ≥78 cm

Exclusion Criteria:

  • Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
  • BP>140/90 or on anti-hypertensive medication
  • Receiving Vitamin D or calcium supplementation
  • Chronic disease-renal/hepatic/malignancy/gastrointestinal
  • On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
  • Febrile illness or infective morbidity in the past 10 days
  • Past history of nephrolithiasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347542

Locations
India
Sitaram Bhartia Institute of Science and Research
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Sitaram Bhartia Institute of Science and Research
Investigators
Principal Investigator: Jitendra N Pande, MD Sitaram Bhartia Institute of Science and Research
Principal Investigator: Jitender Nagpal, MD Sitaram Bhartia Institute of Science and Research
Study Chair: Anupama Singh, MD Sitaram Bhartia Institute of Science and Research
Study Director: Abhishek Bhartia, ME Sitaram Bhartia Institute of Science and Research
  More Information

No publications provided

Responsible Party: Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier: NCT00347542     History of Changes
Other Study ID Numbers: SBISR/2006/03
Study First Received: June 30, 2006
Last Updated: May 31, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Sitaram Bhartia Institute of Science and Research:
Vitamin D
Diabetes
Insulin sensitivity
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Hyperinsulinism
Vitamin D
Ergocalciferols
Vitamins
Insulin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 17, 2013